Single Dose Enteral Tranexamic Acid in Critically Ill Patients

Phase 2

Terminated

• Conditions: Shock; Critical Illness; Sepsis; Hypotension
• Interventions: Drug: Control Intervention (Carrier fluid only); Drug: Tranexamic Acid

• Registration Number: NCT01683747
• Lead Sponsor: San Diego Veterans Healthcare System

Brief Summary

The premise of this study is that enteral tranexamic acid will help to maintain small bowel integrity, which is often compromised by critical illness due to inadequate cardiovascular perfusion (i.e., shock), and that maintenance of small bowel integrity will decrease morbidity in critically ill patients.

Detailed Description

The primary objective of this study is to provide preliminary efficacy and safety data on the enteral administration of a one-time dose of tranexamic acid to critically ill patients for the reduction of morbidity at 28 days after enrollment in the study.

Secondary objectives of this study are to determine the efficacy of administration of enteral tranexamic acid in reducing intensive care unit (ICU) and hospital length-of-stay, as well and mortality and morbidity at 6 months.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-09-09
• Study First Submitted QC: 2012-09-09
• Study First Posted: 2012-09-12
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-16
• Last Update Posted: 2015-11-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• Critically ill patients admitted to ICU within 48 hours of onset of illness
• Patients with feeding tubes (e.g., orogastric, nasogastric, PEG, etc.)

Exclusion Criteria

• primary admitting diagnosis of cancer
• primary admitting diagnosis of acute congestive heart failure
• primary admitting diagnosis of chronic obstructive pulmonary disease (COPD)
• primary admitting diagnosis of acute myocardial infarction or unstable cardiac arrythmia
• primary admitting diagnosis of amyotrophic lateral sclerosis (ALS) or other non-infectious disease
• primary admitting diagnosis of post-operative neurosurgical procedure
• known hypersensitivity to tranexamic acid
• acquired disturbances of color vision
• hematuria cause by disease of the renal parenchyma
• active thromboembolic disease such as deep venous thrombosis or pulmonary embolism
• patients with known clotting disorders or other known bleeding disorders
• recent (within 3 months) or active cerebrovascular bleed
• pregnancy
• inability to take study medicine (i.e., ileus with > 500ml stomach residuals, NPO status)
• patients excluded at the discretion of the treating physician

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control Intervention (Carrier fluid only)	Control group receives vehicle (normal saline) without study drug and usual care.
Tranexamic acid	Tranexamic Acid	Study group receives enteral tranexamic acid in normal saline in addition to usual care.

Primary Outcome Measures

Name	Time	Method
Morbidity	28 days	Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale \[secondary scale\]

Secondary Outcome Measures

Name	Time	Method
mortality	6 months	All cause mortality will be measured at 6 months
ICU length of stay	up to 6 months	Time spent as a patient in the ICU will be measured
Hospital length of stay	up to 6 months	Time spent in the hospital as a patient will be measured
morbidity	6 months	Morbidity will be assessed at 28 days as measured by the validated Self-Administered Quality of Well-being Scale (QWB-SA) and 5-Point modified Oxford Handicap Scale \[secondary scale\]

Trial Locations

Locations (1)

VA San Diego Health Care System; 🇺🇸 San Diego, California, United States